Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix

May 26, 2026 updated by: University of Bern
The aim of this research project is to compare two surgical procedures to improve soft tissue volume. Both procedures have already been validated, but despite their great clinical relevance, little data exists in the literature. With this study, the investigators aim to evaluate volumetric changes of connective tissue graft versus biomaterial (membrane). In addition, further clinical measurements will be taken and patient satisfaction will be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • University of Bern
        • Contact:
        • Principal Investigator:
          • Manrique Fonseca, Dr. med. dent.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Informed Consent signed by the subject
  • Age ≥ 18 years
  • Willingness to sign informed consent and to participate in the study
  • Single tooth gap or extended edentulous space in the lower or posterior jaw including a pontic site with a soft tissue deficiency.
  • Tooth gap of ≥ 8 mm.
  • Presence of natural or artificial opposing dentition
  • Sufficient vertical interocclusal space of an implant restoration (7mm)
  • Bounded by natural and periodontally stable teeth
  • Treatment plan must include tooth replacement with an implant or tooth-supported fixed dental prosthesis.

Exclusion Criteria:

  • Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance with the protocol
  • Severe bruxism, clenching habits, or presence of oro-facial pain
  • Uncontrolled diabetes mellitus (HbA1c >7.0)
  • Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
  • Any active oral or systemic acute infections
  • Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area
  • Severe hematologic disorders
  • Any other diseases or medications that may compromise normal wound healing
  • Pregnancy or nursing mother
  • Contraindications and limitations of the MD as described in the instructions for use: during pregnancy or lactation, children, presence of acute infection in the surgical area, patients with known sensitivity to porcine material or collagen allergies.
  • Vulnerable subjects
  • Known or suspected non-compliance
  • Drug or alcohol abuse
  • Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc.
  • Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
  • Enrolment of the PI, his/her family members, employees and other dependent persons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Group A: Connective Tissue Graft (CTG)
Volumetric changes between groups will be compared by matching intraoral scans before and after surgery (including follow-ups after 5 years) using the engineering software Geo-Magic®.
Experimental: Group B: Volume Collagen Matrix Xenograft (VCMX) Geistlich Fibro-Gide®
The CTG (Group A) is the gold-standard for soft tissue augmentation, therefore it is considered the control group in this investigation.
Device: Geistlich Fibro-Gide®
Geistlich Fibro-Gide® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Volumetric dimensional changes
Time Frame: 0-5 years
To assess the volumetric dimensional changes in pontic sites after site development using CTG compared to VCMX
0-5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical: PPD
Time Frame: 0-5 years
Clinical: Probing depth in neighboring teeth
0-5 years
Clinical BoP
Time Frame: 0-5 years
Clinical: Bleeding on probing
0-5 years
Clinical: Suppuration
Time Frame: 0-5 years
Clinical: Suppuration on probing
0-5 years
Clinical: Mucosa
Time Frame: 0-5 years
Clinical: Apical migration of the marginal mucosa
0-5 years
Clinical: ktw
Time Frame: 0-5 years
Clinical: Keratinized tissue width
0-5 years
Clinical: Mobility
Time Frame: 0-5 years
Clinical: Mobility
0-5 years
Clinical: Thickness
Time Frame: 0-5 years
Clinical: Mucosal thickness
0-5 years
Clinical: Contributing factors
Time Frame: 0-5 years
Clinical: Presence of local contributing factors
0-5 years
Patient-reported satisfaction
Time Frame: 0-5 years
Questionnaire: Overall patient satisfaction with the treatment provided
0-5 years
Patient-reported esthetics
Time Frame: 0-5 years
Questionnaire: Esthetics
0-5 years
Patient-reported discomfort
Time Frame: 0-5 years
Questionnaire: Discomfort
0-5 years
Patient-reported pain
Time Frame: 0-5 years
Questionnaire: Pain
0-5 years
Prosthetics Survival
Time Frame: 0-5 years
Prosthetic-related: Fixed dental prostheses survival rates
0-5 years
Prosthetics Complications
Time Frame: 0-5 years
Prosthetic-related: Technical complications
0-5 years
Prosthetics PES-WES
Time Frame: 0-5 years
Prosthetic-related: Esthetic score (PES-WES)
0-5 years
Prosthetics: Occlusal
Time Frame: 0-5 years
Prosthetic-related: Occlusal contacts (static and dynamic)
0-5 years
Prosthetics: Interproximal
Time Frame: 0-5 years
Prosthetic-related: Presence of interproximal contacts.
0-5 years
Radiographics BL
Time Frame: 0-5 years
Marginal bone levels
0-5 years
Radiographics PP
Time Frame: 0-5 years
Periapical pathosis
0-5 years
Radiographics distance
Time Frame: 0-5 years
Distance from the adjacent teeth/implants
0-5 years
Radiographics Contacts
Time Frame: 0-5 years
Presence of open contacts
0-5 years
Prosthetics Success
Time Frame: 0-5 years
Prosthetic-related: Fixed dental prostheses success rates
0-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manrique Fonseca, DDS, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCT: CTG-VCMX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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